BUPRENORPHINE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)

Disponible desde:

American Health Packaging

Vía de administración:

SUBLINGUAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)]. Risk Summary The data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data]. Observational studies have reported on congenital malformations among buprenorphine-e

Resumen del producto:

Buprenorphine Sublingual Tablets are available in the following strengths: 2 mg – White to off-white, round flat-faced beveled edged tablet debossed with "RP" on one side and "b2" on the other side (content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP). Unit dose packages of 30 (3 x 10) NDC 60687-481-21 8 mg – White to off-white, round flat-faced beveled edged tablet debossed with "RP" on one side and "b8" on the other side (content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP). Unit dose packages of 30 (3 x 10) NDC 60687-492-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store Buprenorphine Sublingual Tablets securely and dispose of properly [see Patient Counseling Information (17)]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

BUPRENORPHINE- BUPRENORPHINE TABLET
American Health Packaging
----------
MEDICATION GUIDE
8448121/0822
Buprenorphine (byoo-pre-NOR-feen)
Sublingual Tablets, CIII
IMPORTANT:
Keep buprenorphine sublingual tablets in a secure place away from
children. Accidental use by a child is a
medical emergency and can result in death. If a child accidentally
takes buprenorphine sublingual tablets, get
emergency help or call 911 right away. Tell your healthcare provider
if you are living in a household where
there are small children.
What is the most important information I should know about
buprenorphine sublingual tablets?
•
Buprenorphine sublingual tablets contain a medicine called
buprenorphine. Buprenorphine is an
opioid that can cause serious and life-threatening breathing problems,
especially if you take or use
certain other medicines or drugs.
•
Talk to your healthcare provider about naloxone. Naloxone is a
medicine that is available to patients
for the emergency treatment of an opioid overdose, including
accidental use of buprenorphine
sublingual tablets by a child. If naloxone is given, you must call 911
or get emergency medical help
right away to treat an overdose or accidental use of an opioid.
•
Buprenorphine sublingual tablets may cause serious and
life-threatening breathing problems. Get
emergency help right away if you:
•
feel faint
•
have blurred vision
•
feel dizzy
•
have slurred speech
•
are confused
•
are breathing slower than normal
•
feel sleepy or uncoordinated
•
cannot think well or clearly
•
Do not take buprenorphine sublingual tablets with certain medicines.
Taking buprenorphine
sublingual tablets with other opioid medicines, benzodiazepines,
alcohol, or other central nervous
system depressants (including street drugs) can cause severe
drowsiness, decreased awareness,
breathing problems, coma, and death.
•
Do not inject (“shoot-up”) buprenorphine sublingual tablets.
Injecting buprenorphine sublingual
tablets may cause life-threatening infections and other serious health
pr

Ficha técnica

BUPRENORPHINE- BUPRENORPHINE TABLET
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE
SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPRENORPHINE SUBLINGUAL TABLETS.
BUPRENORPHINE SUBLINGUAL TABLETS, CIII
INITIAL U.S. APPROVAL: 1981
RECENT MAJOR CHANGES
Dosage and Administration (
2.6)                    06/2022
Warnings and Precautions ( 5.13, 5.14)
                 06/2022
INDICATIONS AND USAGE
Buprenorphine sublingual tablets, contain buprenorphine, a partial
opioid agonist, and are indicated for the
treatment of opioid dependence and are preferred for induction. ( 1)
Buprenorphine sublingual tablets should be used as part of a complete
treatment plan that includes
counseling and psychosocial support. ( 1)
DOSAGE AND ADMINISTRATION
Prescription use of this product is limited under the Drug Addiction
Treatment Act. ( 2.1)
Administer buprenorphine sublingual tablets sublingually as a single
daily dose. ( 2.2)
Strongly consider prescribing naloxone at the time buprenorphine
sublingual tablets are initiated or
renewed because patients being treated for opioid use disorder have
the potential for relapse, putting
them at risk for opioid overdose. ( 2.3)
To avoid precipitating withdrawal, induction with buprenorphine
sublingual tablets should be undertaken
when objective and clear signs of withdrawal are evident. ( 2.4).
Buprenorphine and naloxone sublingual film or buprenorphine and
naloxone sublingual tablets are
generally initiated after two days of buprenorphine sublingual tablet
titration. ( 2.5)
Administer buprenorphine sublingual tablets as directed in the Full
Prescribing Information. ( 2.4,2.5,
2.6)
Buprenorphine sublingual tablets must be administered whole. Do not
cut, chew, or swallow
buprenorphine sublingual tablets ( 2.6)
When discontinuing treatment, gradually taper to avoid signs and
symptoms